Status:

WITHDRAWN

Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

Lead Sponsor:

Kirby Institute

Conditions:

Hepatitis B

Eligibility:

All Genders

18+ years

Brief Summary

Evaluation of novel point of care Hepatitis B diagnostic assays.

Detailed Description

This study aims to evaluate the sensitivity of the following novel assays for evaluation of HBV infection and assessment of treatment eligibility; * GeneXpert HBV DNA via Fingerstick testing, * Dried...

Eligibility Criteria

Inclusion

  • Have voluntarily signed the informed consent form.
  • 18 years of age or older.
  • HBsAg positive
  • Part A: Not currently on antiviral therapy for HBV and HBV DNA detectable OR Part B: Stable on HBV antiviral therapy for at least 3 months with HBV DNA \< 20 IU/ml

Exclusion

  • 1\) Inability or unwillingness to provide informed consent or abide by the requirements of the study.

Key Trial Info

Start Date :

January 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2022

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04289428

Start Date

January 1 2022

End Date

October 1 2022

Last Update

December 3 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia, 2010